| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BRT | Restraint, Patient, Conductive | 第 1 类 | 21 CFR 880.6760 | |
| BRZ | Set, Blood Transfusion | 第 2 类 | 21 CFR 880.5440 | 30 |
| BWJ | Locator, Acupuncture Point | 第 2 类 | 21 CFR 880.5580 | 3 |
| BYY | Tube, Aspirating, Flexible, Connecting | 第 2 类 | 21 CFR 880.6740 | 24 |
| BYZ | Trap, Sterile Specimen | 第 2 类 | 21 CFR 880.6740 | 9 |
| CAK | Microfilter, Blood Transfusion | 第 2 类 | 21 CFR 880.5440 | 36 |
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | 第 2 类 | 21 CFR 880.2460 | 3 |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | 第 2 类 | 21 CFR 880.6740 | 3 |
| CBD | Bottle, Collection, Breathing System (Calibrated) | 第 2 类 | 21 CFR 880.6740 | 3 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 第 2 类 | 21 CFR 880.5780 | 64 |
| FLE | Sterilizer, Steam | 第 2 类 | 21 CFR 880.6880 | 185 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 第 2 类 | 21 CFR 880.6860 | 26 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 第 1 类 | 21 CFR 880.6150 | 19 |
| FLH | Washer Of Body Waste Receptacles | 第 1 类 | 21 CFR 880.6800 | |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | 第 2 类 | 21 CFR 880.6100 | 8 |
| FLK | Thermometer, Clinical Mercury | 第 2 类 | 21 CFR 880.2920 | 33 |
| FLL | Continuous Measurement Thermometer | 第 2 类 | 21 CFR 880.2910 | 798 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 第 2 类 | 21 CFR 880.2420 | 39 |
| FMA | Depressor, Tongue, Non-Surgical | 第 1 类 | 21 CFR 880.6230 | 5 |
| FMC | Patient Examination Glove | 第 1 类 | 21 CFR 880.6250 | 34 |
| FME | Gown, Examination | 第 1 类 | 21 CFR 880.6265 | 5 |
| FMF | Syringe, Piston | 第 2 类 | 21 CFR 880.5860 | 752 |
| FMG | Stopcock, I.V. Set | 第 2 类 | 21 CFR 880.5440 | 89 |
| FMI | Needle, Hypodermic, Single Lumen | 第 2 类 | 21 CFR 880.5570 | 693 |
| FMJ | Manometer, Spinal-Fluid | 第 2 类 | 21 CFR 880.2500 | 6 |
| FML | Chair, Blood Donor | 第 1 类 | 21 CFR 880.6140 | 2 |
| FMP | Protector, Skin Pressure | 第 1 类 | 21 CFR 880.6450 | 23 |
| FMQ | Restraint, Protective | 第 1 类 | 21 CFR 880.6760 | 134 |
| FMR | Device, Transfer, Patient, Manual | 第 1 类 | 21 CFR 880.6785 | 5 |
| FMS | Bed, Pediatric Open Hospital | 第 2 类 | 21 CFR 880.5140 | 27 |
| FMT | Warmer, Infant Radiant | 第 2 类 | 21 CFR 880.5130 | 92 |
| FMW | Cover, Mattress (Medical Purposes) | 第 1 类 | 21 CFR 880.6190 | 14 |
| FMZ | Incubator, Neonatal | 第 2 类 | 21 CFR 880.5400 | 86 |
| FNG | Lift, Patient, Ac-Powered | 第 2 类 | 21 CFR 880.5500 | 21 |
| FNJ | Bed, Manual | 第 1 类 | 21 CFR 880.5120 | 39 |
| FNK | Bed, Hydraulic, Adjustable Hospital | 第 1 类 | 21 CFR 880.5110 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 第 2 类 | 21 CFR 880.5100 | 70 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 第 2 类 | 21 CFR 880.5550 | 102 |
| FNN | Nipple, Lambs Feeding | 第 1 类 | 21 CFR 880.5640 | |
| FNP | Urinal | 第 1 类 | 21 CFR 880.6730 | 1 |
| FNS | Ring Cutter | 第 1 类 | 21 CFR 880.6200 | |
| FNY | Basin, Emesis | 第 1 类 | 21 CFR 880.6730 | 9 |
| FOA | Board, Cardiopulmonary | 第 1 类 | 21 CFR 880.6080 | 3 |
| FOB | Bedpan | 第 1 类 | 21 CFR 880.6730 | 5 |
| FOD | Device, Occlusion, Umbilical | 第 1 类 | 21 CFR 880.5950 | |
| FOH | Mattress, Water, Temperature Regulated | 第 1 类 | 21 CFR 880.5560 | 6 |
| FOK | Pad, Neonatal Eye | 第 1 类 | 21 CFR 880.5270 | 5 |
| FOS | Catheter, Umbilical Artery | 第 2 类 | 21 CFR 880.5200 | 34 |
| FOX | Stand, Infusion | 第 1 类 | 21 CFR 880.6990 | 36 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 第 2 类 | 21 CFR 880.5200 | 507 |
| FPA | Set, Administration, Intravascular | 第 2 类 | 21 CFR 880.5440 | 1174 |
| FPB | Filter, Infusion Line | 第 2 类 | 21 CFR 880.5440 | 98 |
| FPF | Bottle, Hot/Cold Water | 第 1 类 | 21 CFR 880.6085 | 1 |
| FPK | Tubing, Fluid Delivery | 第 2 类 | 21 CFR 880.5440 | 64 |
| FPL | Incubator, Neonatal Transport | 第 2 类 | 21 CFR 880.5410 | 25 |
| FPO | Stretcher, Wheeled | 第 2 类 | 21 CFR 880.6910 | 50 |
| FPP | Stretcher, Hand-Carried | 第 1 类 | 21 CFR 880.6900 | 39 |
| FPS | Board, Bed | 第 1 类 | 21 CFR 880.6070 | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 第 1 类 | 21 CFR 880.5240 | 35 |
| FPY | Sheet, Burn | 第 1 类 | 21 CFR 880.5180 | 17 |
| FQA | Scale, Surgical Sponge | 第 1 类 | 21 CFR 880.2740 | 1 |
| FQH | Lavage, Jet | 第 2 类 | 21 CFR 880.5475 | 53 |
| FQJ | Support, Scrotal, Therapeutic | 第 1 类 | 21 CFR 880.5820 | |
| FQK | Binder, Perineal | 第 1 类 | 21 CFR 880.5160 | |
| FQL | Stocking, Medical Support (For General Medical Purposes) | 第 1 类 | 21 CFR 880.5780 | 6 |
| FQM | Bandage, Elastic | 第 1 类 | 21 CFR 880.5075 | 42 |
| FQZ | Thermometer, Clinical Color Change | 第 1 类 | 21 CFR 880.2900 | 14 |
| FRA | Purifier, Air, Ultraviolet, Medical | 第 2 类 | 21 CFR 880.6500 | 36 |
| FRC | Indicator, Biological Sterilization Process | 第 2 类 | 21 CFR 880.2800 | 206 |
| FRF | Cleaner, Air, Medical Recirculating | 第 2 类 | 21 CFR 880.5045 | 53 |
| FRG | Wrap, Sterilization | 第 2 类 | 21 CFR 880.6850 | 323 |
| FRI | Scale, Stand-On, Patient | 第 1 类 | 21 CFR 880.2700 | 3 |
| FRJ | Chair, Geriatric | 第 1 类 | 21 CFR 880.6140 | |
| FRK | Chair, Examination And Treatment | 第 1 类 | 21 CFR 880.6140 | 4 |
| FRL | Fiber, Medical, Absorbent | 第 1 类 | 21 CFR 880.5300 | 19 |
| FRN | Pump, Infusion | 第 2 类 | 21 CFR 880.5725 | 849 |
| FRP | Holder, Infant Position | 第 1 类 | 21 CFR 880.5680 | 14 |
| FRR | Chamber, Reverse Isolation, Patient Care | 第 2 类 | 21 CFR 880.5450 | 1 |
| FRW | Scale, Patient | 第 1 类 | 21 CFR 880.2720 | 48 |
| FRZ | Device, Patient Transfer, Powered | 第 2 类 | 21 CFR 880.6775 | 5 |
| FSA | Lift, Patient, Non-Ac-Powered | 第 1 类 | 21 CFR 880.5510 | 13 |
| FSD | Binder, Abdominal | 第 1 类 | 21 CFR 880.5160 | 5 |
| GAG | Stapler, Surgical | 第 2 类 | 21 CFR 878.4740 | 43 |
| GAZ | Tubing, Noninvasive | 第 2 类 | 21 CFR 880.6740 | 27 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 第 2 类 | 21 CFR 880.6740 | 87 |
| HEF | Binder, Breast | 第 1 类 | 21 CFR 880.5160 | |
| HFS | Shield, Nipple | 第 1 类 | 21 CFR 880.5630 | 12 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 第 1 类 | 21 CFR 880.5150 | 8 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 第 2 类 | 21 CFR 880.2800 | 264 |
| JOK | Scissors, Medical, Disposable | 第 1 类 | 21 CFR 880.6820 | 7 |
| JOL | Catheter And Tip, Suction | 第 2 类 | 21 CFR 880.6740 | 84 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 第 2 类 | 21 CFR 880.6850 | 280 |
| KDP | Regulator, Vacuum | 第 2 类 | 21 CFR 880.6740 | 21 |
| KDQ | Bottle, Collection, Vacuum | 第 2 类 | 21 CFR 880.6740 | 48 |
| KGX | Tape And Bandage, Adhesive | 第 1 类 | 21 CFR 880.5240 | 187 |
| KIA | Cover, Cast | 第 1 类 | 21 CFR 880.6185 | 1 |
| KME | Bedding, Disposable, Medical | 第 1 类 | 21 CFR 880.6060 | 65 |
| KMF | Bandage, Liquid | 第 1 类 | 21 CFR 880.5090 | 222 |
| KMG | Purifier, Water, Ultraviolet, Medical | 第 2 类 | 21 CFR 880.6710 | 9 |
| KMH | Sterilizer, Dry Heat | 第 2 类 | 21 CFR 880.6870 | 10 |
| KMI | Monitor, Bed Patient | 第 1 类 | 21 CFR 880.2400 | 31 |
| KMJ | Lubricant, Patient | 第 1 类 | 21 CFR 880.6375 | 49 |
| KMK | Device, Intravascular Catheter Securement | 第 1 类 | 21 CFR 880.5210 | 64 |
| KMN | Chair And Table, Medical | 第 1 类 | 21 CFR 880.6140 | 3 |
| KMO | Binder, Elastic | 第 1 类 | 21 CFR 880.5160 | 5 |
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 第 2 类 | 21 CFR 880.2200 | 21 |
| KPE | Container, I.V. | 第 2 类 | 21 CFR 880.5025 | 117 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 第 1 类 | 21 CFR 880.6025 | 21 |
| KXG | Applicator, Absorbent Tipped, Sterile | 第 1 类 | 21 CFR 880.6025 | 1 |
| KYP | Snake Bite Suction Kit | 第 1 类 | 21 CFR 880.5740 | 4 |
| KYQ | Kit, Chemical Snake-Bite | 第 3 类 | 21 CFR 880.5760 | |
| KYR | Bag, Ice | 第 1 类 | 21 CFR 880.6050 | 4 |
| KYS | Insoles, Medical | 第 1 类 | 21 CFR 880.6280 | 1 |
| KYT | Light, Examination, Medical, Battery Powered | 第 1 类 | 21 CFR 880.6350 | 6 |
| KYW | Container, Liquid Medication, Graduated | 第 1 类 | 21 CFR 880.6430 | 2 |
| KYX | Dispenser, Liquid Medication | 第 1 类 | 21 CFR 880.6430 | 11 |
| KYZ | Syringe, Irrigating (Non Dental) | 第 1 类 | 21 CFR 880.6960 | 41 |
| KZA | Device, Vein Location, Liquid Crystal | 第 1 类 | 21 CFR 880.6970 | 6 |
| KZD | Infusor, Pressure, For I.V. Bags | 第 1 类 | 21 CFR 880.5420 | 35 |
| KZE | Injector, Fluid, Non-Electrically Powered | 第 2 类 | 21 CFR 880.5430 | 53 |
| KZF | Device, Medical Examination, Ac Powered | 第 1 类 | 21 CFR 880.6320 | 37 |
| KZH | Introducer, Syringe Needle | 第 2 类 | 21 CFR 880.6920 | 47 |
| LBI | Unit, Neonatal Phototherapy | 第 2 类 | 21 CFR 880.5700 | 71 |
| LBJ | Device, Vein Stabilization | 第 1 类 | 21 CFR 880.6980 | |
| LDR | Controller, Infusion, Intravascular, Electronic | 第 2 类 | 21 CFR 880.5725 | 60 |
| LDS | Device, Pasteurization, Hot Water | 第 2 类 | 21 CFR 880.6991 | 11 |
| LFE | Solution, Cold Sterilizing | 第 2 类 | 21 CFR 880.6885 | 1 |
| LGM | Chamber, Patient Isolation | 第 2 类 | 21 CFR 880.5450 | 12 |
| LGN | Chamber, Patient Transport Isolation | 第 2 类 | 21 CFR 880.5450 | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | 第 2 类 | 21 CFR 880.5725 | 75 |
| LHB | Timer, Apgar | 第 1 类 | 21 CFR 880.2930 | 2 |
| LHF | Warmer, Microwave, Infusion Fluid | 第 2 类 | 21 CFR 880.5725 | 2 |
| LHI | Set, I.V. Fluid Transfer | 第 2 类 | 21 CFR 880.5440 | 206 |
| LJL | Detectors And Removers, Lice, (Including Combs) | 第 1 类 | 21 CFR 880.5960 | 11 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 第 2 类 | 21 CFR 880.5970 | 302 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 第 2 类 | 21 CFR 880.5965 | 288 |
| LLD | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal | 第 2 类 | 21 CFR 880.5965 | 4 |
| LLI | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use | 第 2 类 | 21 CFR 880.5100 | 2 |
| LLK | Legging, Compression, Non-Inflatable | 第 2 类 | 21 CFR 880.5780 | 4 |
| LRJ | Disinfectant, Medical Devices | 第 1 类 | 21 CFR 880.6890 | 73 |
| LRS | I.V. Start Kit | 第 2 类 | 21 CFR 880.5200 | 30 |
| LRT | Indicator, Sterilization | 第 2 类 | 21 CFR 880.2800 | 5 |
| LWH | Counter, Sponge, Surgical | 第 1 类 | 21 CFR 880.2740 | 15 |
| LYY | Latex Patient Examination Glove | 第 1 类 | 21 CFR 880.6250 | 1954 |
| LYZ | Vinyl Patient Examination Glove | 第 1 类 | 21 CFR 880.6250 | 799 |
| LZA | Polymer Patient Examination Glove | 第 1 类 | 21 CFR 880.6250 | 1176 |
| LZB | Finger Cot | 第 1 类 | 21 CFR 880.6250 | 5 |
| LZC | Medical Glove, Specialty | 第 1 类 | 21 CFR 880.6250 | 79 |
| LZF | Pump, Infusion, Analytical Sampling | 第 2 类 | 21 CFR 880.5725 | 7 |
| LZG | Pump, Infusion, Insulin | 第 2 类 | 21 CFR 880.5725 | 84 |
| LZH | Pump, Infusion, Enteral | 第 2 类 | 21 CFR 880.5725 | 34 |
| MCY | Wound Dressing Kit | 第 2 类 | 21 CFR 880.5075 | 24 |
| MDR | Binder, Medical, Therapeutic | 第 1 类 | 21 CFR 880.5160 | |
| MDZ | Cleaners, Medical Devices | 第 2 类 | 21 CFR 880.6992 | 2 |
| MEA | Pump, Infusion, Pca | 第 2 类 | 21 CFR 880.5725 | 31 |
| MEB | Pump, Infusion, Elastomeric | 第 2 类 | 21 CFR 880.5725 | 88 |
| MEC | Disinfector, Medical Devices | 第 2 类 | 21 CFR 880.6992 | 2 |
| MED | Sterilant, Medical Devices | 第 2 类 | 21 CFR 880.6885 | 64 |
| MEG | Syringe, Antistick | 第 2 类 | 21 CFR 880.5860 | 162 |
| MHC | Needle, Interosseous | 第 2 类 | 21 CFR 880.5570 | 2 |
| MHD | Pump, Infusion, Gallstone Dissolution | 第 2 类 | 21 CFR 880.5725 | 1 |
| MHW | Dressing, Compression | 第 1 类 | 21 CFR 880.5075 | 2 |
| MJF | Check Valve, Retrograde Flow (In-Line) | 第 2 类 | 21 CFR 880.5440 | 1 |
| MKB | Device, Germicidal, Ultraviolet | 第 2 类 | 21 CFR 880.6500 | |
| MLR | Sterilizer, Chemical | 第 2 类 | 21 CFR 880.6860 | 47 |
| MMK | Container, Sharps | 第 2 类 | 21 CFR 880.5570 | 114 |
| MMS | Lubricant, Vaginal, Patient | 第 1 类 | 21 CFR 880.6375 | |
| MQX | Needle, Acupuncture, Single Use | 第 2 类 | 21 CFR 880.5580 | 91 |
| MRB | Indicator, Biological, Liquid Chemical Sterilization Process | 第 2 类 | 21 CFR 880.2800 | 4 |
| MRH | Pump, Infusion, Ophthalmic | 第 2 类 | 21 CFR 880.5725 | 20 |
| MRL | Scale, Sponge, Surgical, Electrically-Powered | 第 1 类 | 21 CFR 880.2740 | 1 |
| MRZ | Accessories, Pump, Infusion | 第 2 类 | 21 CFR 880.5725 | 48 |
| MTC | Indicator, Chemical, Enzymatic, Sterilization Process | 第 2 类 | 21 CFR 880.2800 | 2 |
| MTV | Sharps Needle Destruction Device | 第 2 类 | 21 CFR 880.6210 | 1 |
| MZM | Fibrin Sealant Preparation Device | 第 2 类 | 21 CFR 880.5860 | |
| MZR | Topical Approximation System | 第 1 类 | 21 CFR 880.5240 | |
| NEC | Bandage, Liquid, Skin Protectant | 第 1 类 | 21 CFR 880.5090 | 3 |
| NEP | System/Device, Pharmacy Compounding | 第 2 类 | 21 CFR 880.5440 | |
| NGT | Saline, Vascular Access Flush | 第 2 类 | 21 CFR 880.5200 | 40 |
| NKK | Needle, Hypodermic, Single Lumen, Reprocessed | 第 2 类 | 21 CFR 880.5570 | |
| NKN | Syringe, Piston, Reprocessed | 第 2 类 | 21 CFR 880.5860 | |
| NRV | Implantable Radio Frequency Transponder System | 第 2 类 | 21 CFR 880.6300 | 1 |
| NRW | Stimulator, Intramuscular, Automatic | 第 2 类 | 21 CFR 880.5580 | 1 |
| NSC | Injector, Pen | 第 2 类 | 21 CFR 880.5860 | 1 |
| NTC | Nursing Pad, Hydrogel | 第 1 类 | 21 CFR 880.5630 | 1 |
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Sur | 第 1 类 | 21 CFR 880.5630 | 1 |
| NUP | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | 第 2 类 | 21 CFR 880.5045 | 8 |
| NXH | Nursing Pad, Cohesive Gel | 第 1 类 | 21 CFR 880.5630 | 1 |
| NZD | Stretcher, Patient Restraint | 第 1 类 | 21 CFR 880.6900 | 1 |
| NZG | Bassinet, Hospital | 第 2 类 | 21 CFR 880.5145 | |
| NZH | Medication Management System, Remote | 第 2 类 | 21 CFR 880.6315 | 2 |
| NZJ | Respirator, N95, For Use By The General Public In Public Health Medica | 第 2 类 | 21 CFR 880.6260 | 2 |
| NZW | Heparin, Vascular Access Flush | 第 2 类 | 21 CFR 880.5200 | 7 |
| NZX | Water, Vascular Access Flush | 第 2 类 | 21 CFR 880.5200 | |
| OBK | Port, Protector/Cushion | 第 2 类 | 21 CFR 880.5965 | 1 |
| OCI | Indicator, Physical/Chemical, Storage Temperature | 第 2 类 | 21 CFR 880.2800 | 1 |
| ODI | Administration Set Docking Station | 第 2 类 | 21 CFR 880.5440 | 1 |
| ODY | Tunneled Catheter Remover | 第 2 类 | 21 CFR 880.5970 | 2 |
| OGQ | Ear Irrigation Kit | 第 1 类 | 21 CFR 880.6960 | |
| OHY | Pill Crusher/Cutter | 第 1 类 | 21 CFR 880.6430 | |